RESOLUTE Japan - The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent

NCT ID: NCT00927940

Last Updated: 2015-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2015-02-28

Brief Summary

The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent for the treatment of de novo lesions in native coronary arteries.

Conditions

Arterial Occlusive Diseases; Myocardial Ischemia; Cardiovascular Diseases; Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug Eluting Stent

All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.

Group Type: EXPERIMENTAL

MDT-4107 Drug Eluting Stent

Intervention Type: DEVICE

Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent

Interventions

MDT-4107 Drug Eluting Stent

Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent

Intervention Type: DEVICE

Other Intervention Names

Zotarolimus Eluting Coronary Stent

Eligibility Criteria

Inclusion Criteria

• Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
• Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
• Informed consent
• Patient agrees to comply with specified follow-up evaluations at same investigational site
• Single target lesion or two target lesions located in separate coronary arteries
• De novo lesion(s) in native coronary artery(ies)
• Target lesion(s) ≤ 27 mm in length
• Target vessel(s) have reference vessel diameter 2.5 mm to 3.5 mm

Exclusion Criteria

• Within 7 days of implant platelet count <100,000 cells/mm³ or >700,000 cells/mm³; white blood cell (WBC) count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl
• Acute myocadial infarction (MI) within 72 hrs of the index procedure (Q wave myocardial infarction(QWMI) or any elevation of Creatinine Kinase Mycocardial-band Isoemzyme (CK-MB) > lab upper limit of normal)
• Previous PCI of target vessel(s) within 9 months prior to the procedure
• Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
• History of stroke or transient ischemic attack (TIA) within prior 6 months
• Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
• Inability to comply with required trial antiplatelet regimen
• Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
• Target vessel(s) has/have other lesions w/ > 40% diameter stenosis
• Unprotected left main coronary artery disease

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Japan Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Medtronic Vascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shigeru Saito, MD

Role: PRINCIPAL_INVESTIGATOR

Shonan Kamakura General Hospital

Locations

Toyohashi Heart Center

Aichi, , Japan

Hospital Hakodate Hokkaido

Hokkaido, , Japan

Kansai Rosai Hospital

Hyōgo, , Japan

Kanto Rosai Hospital

Kanagawa, , Japan

Yokohama Tobu Hospital

Kanagawa, , Japan

Shonan Kamakura General Hospital

Kanagawa, , Japan

Kumamoto Rosai Hospital

Kumamoto, , Japan

Kyoto Katsura Hospital

Kyoto, , Japan

Kurashiki Central Hospital

Okayama, , Japan

Jichi Medical University Hospital

Tochigi, , Japan

The Cardiovascular Institute Hospital

Tokyo, , Japan

Showa University Hospita

Tokyo, , Japan

Toho University Medical Center, Ohashi Hospital

Tokyo, , Japan

Teikyo University Hospital

Tokyo, , Japan

Countries

Japan

References

Saito S, Maehara A, Vlachojannis GJ, Parise H, Mehran R; RESOLUTE Japan Investigators. Clinical and angiographic evaluation of the resolute zotarolimus-eluting coronary stent in Japanese patients - long-term outcome in the RESOLUTE Japan and RESOLUTE Japan small vessel study. Circ J. 2015;79(1):96-103. doi: 10.1253/circj.CJ-14-0836. Epub 2014 Nov 27.

Reference Type: DERIVED

PMID: 25428602 (View on PubMed)

Silber S, Kirtane AJ, Belardi JA, Liu M, Brar S, Rothman M, Windecker S. Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation. Eur Heart J. 2014 Aug 1;35(29):1949-56. doi: 10.1093/eurheartj/ehu026. Epub 2014 Feb 7.

Reference Type: DERIVED

PMID: 24510638 (View on PubMed)

Silber S, Serruys PW, Leon MB, Meredith IT, Windecker S, Neumann FJ, Belardi J, Widimsky P, Massaro J, Novack V, Yeung AC, Saito S, Mauri L. Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program. JACC Cardiovasc Interv. 2013 Apr;6(4):357-68. doi: 10.1016/j.jcin.2012.11.006. Epub 2013 Mar 20.

Reference Type: DERIVED

PMID: 23523454 (View on PubMed)

Farooq V, Vranckx P, Mauri L, Cutlip DE, Belardi J, Silber S, Widimsky P, Leon M, Windecker S, Meredith I, Negoita M, van Leeuwen F, Neumann FJ, Yeung AC, Garcia-Garcia HM, Serruys PW. Impact of overlapping newer generation drug-eluting stents on clinical and angiographic outcomes: pooled analysis of five trials from the international Global RESOLUTE Program. Heart. 2013 May;99(9):626-33. doi: 10.1136/heartjnl-2012-303368. Epub 2013 Mar 6.

Reference Type: DERIVED

PMID: 23468513 (View on PubMed)

Related Links

http://clinicaltrials.medtronic.com/

Medtronic Clinical Trials Link

Other Identifiers

MDT2-07-03

Identifier Type: -

Identifier Source: org_study_id